Atarax

NDA 10485, held by Roerig. Hydroxyzine Hydrochloride.

As of Nov 14, 2026, NDA 10485 (Atarax), held by Roerig, was first approved by FDA on May 31, 1956, with 3 approved supplements and 0 published complete response letters.

First approved: May 31, 1956
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
May 31, 1956	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Atarax10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · syrup;oral	Hydroxyzine Hydrochloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Mar 21, 2001	Supplement 18Labeling · Standard review	Approved	Letter
May 20, 1985	Supplement 16Labeling	Approved	None posted
May 21, 1979	Supplement 11Labeling	Approved	None posted
May 31, 1956	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 10485
Drugs@FDA: Overview at FDA
Company: Roerig

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters